FDA Recall
Ongoing
Historical recordClass I
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
by SHOPPERS- PLAZA
- Reason
- Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
- Published
- January 29, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
by First Aid Beauty Ltd
- Reason
- CGMP Deviations; product intended for quarantine was inadvertently distributed
- Published
- January 29, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
by Brands International Corporation
- Reason
- CGMP Deviations: lack of adequate release testing.
- Published
- January 29, 2025
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
by Viatris Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93
by Viatris Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications:
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
by Amerisource Health Services LLC
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
by Alcon Research LLC
- Reason
- Non-Sterility
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
by Akron Pharma, Inc.
- Reason
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Eclectic Institute Inc
- Product
- Eclectic Herb Vitamin Herb Blend vita biotic dietary supplem…
- Reason
- Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel.
- Published
- January 22, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
by Rising Pharma Holding, Inc.
- Reason
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05.
by Jubilant Draximage Inc., dba Jubilant Radiopharma
- Reason
- Failed Stability Specifications
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
by Rising Pharma Holding, Inc.
- Reason
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
by Rising Pharma Holding, Inc.
- Reason
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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